The FDA handed a complete response letter to Mesoblast for its BLA submission of its drug for pediatric steroid-refractory acute graft-versus-host disease (SR-aGVHD), the company announced Friday, adding another delay in a winding journey for remestemcel-L.
The agency wants more data in adult patients before it will approve the drug. Mesoblast said it’s planning on a controlled study in high-risk adults whose previous therapies haven’t worked and whose 90-day survival is as low as 20% to 30%. The adult study is in line with what it had planned to do in a sequential move from pediatric to adult SR-aGVHD, as adults make up 80% of the market for the disease, the company added in its statement.
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